K-number	K210181
Device name	Nordiwell Surgical Face Mask
Applicant	Changzhou Combat Protective Equipment Co., Ltd.
Product code	FXX
Device class	Class II
Decision date	Mar 9, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Nordiwell Surgical Face Mask

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